Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

Maastricht University Medical Centre (MUMC)

Status and phase: Not yet enrolling; Phase 4

Conditions: Recurrent Candidiasis of Vagina; Candidiasis, Vulvovaginal

Treatments: Drug: Fluconazole; Other: L-Mesitran

Study type: Interventional

Funder types: Other

Identifiers

NCT04626258

NL 73794.068.20

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.

Enrollment: 252 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Women of at least 18 years old

  • Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
  • Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
  • Capacity to understand, consent, and comply with the trial procedures

Exclusion criteria

• Mixed vaginal infections

  • Pregnancy or the intention to become pregnant during the study period
  • Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
  • Known allergies for Fluconazole or honey
  • Candida with resistance for Fluconazole

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Active comparator: Fluconazol

Active Comparator group

Description:

Once a month one capsule Fluconazol 150 mg

Treatment:

Drug: Fluconazole

L-Mesitran

Experimental group

Description:

The first month every day apply L-mesitran, the next five months apply L-mesitran every week on the vagina

Treatment:

Other: L-Mesitran